MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE; CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Catalog Number	364958
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
Report 1 of 2: it was reported during use of bd vacutainer® boric acid sodium borate/formate c&s urine tube, an unspecified number of tubes are not reseating on their automated instrument (copan wasp) ; caps are loose and causing spills.There was no health impact or consequences reported.
Event or Problem Description
Report 1 of 2: it was reported during use of bd vacutainer® boric acid sodium borate/formate c&s urine tube, an unspecified number of tubes are not reseating on their automated instrument (copan wasp) ; caps are loose and causing spills.There was no health impact or consequences reported.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes.H3: device eval by manufacturer? yes.D9: returned to manufacturer on: 21-jan-2025.Investigation summary: bd received customer return samples (sent directly to franklin lakes) for investigation.100 retention samples were visually inspected with no issues identified.Additionally, 10 retain samples were functionally tested for stopper function and no issues were observed: no issues with closure assembly being loose or separating after functional testing.Additionally, factors that may contribute to stopper function were evaluated through a clinical study to verify the design of the device met it¿s intended use.The result of the study showed that the device performed as expected and we were unable to determine any external contributor to this reported issue.The additional testing was performed at franklin lakes: both customer¿s samples and retained samples from lot# 4043778, exp aug 31, 2025 were tested to characterize stopper pull-out force, and both samples passed bd performance requirements with no stopper shield separation.8 contaminated samples were also sent from the customer, but lot number cannot be identified due to double labelling (customer¿s label over bd label).Bd does not have a procedure to test contaminated samples, so these samples were not tested.Design of experiments were performed to study potential factors influencing the stopper pull-out at the customer's site.Lot # 3227753 (exp feb 28, 2025) and lot # 4212945, (exp jab 31, 2026) from the customer¿s site, a fresh lot (lot #4346731, exp jun 30, 2026) pulled from bd distribution center and a competitor¿s lot were tested in the study.Investigation conclusion: bd and competitor¿s tube have similar range of pullout force while bd has a tighter confidence interval.Lot # 4212945 has a lower pullout force, while it remains within bd specification.There have not been any other complaints on this lot as of april 2, 2025.Slightly off-centered alignment and higher recap force from the instrument could make lot #4212945 perform sub-optimally.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode stopper function/loose stopper.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE
• Common Device Name: CULTURE MEDIA, NON-PROPAGATING TRANSPORT
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 21265527
• Report Number: 1917413-2025-00026
• Device Sequence Number: 17277731
• Product Code: JSM
• UDI-Device Identifier: 50382903649582
• UDI-Public: (01)50382903649582(11)240212(17)250831(10)4043778
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K024240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 364958
• Device Lot Number: 4043778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown